MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CURVED LONG INCISOR PLUS ELITE BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200494
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, pieces of the long incisor elite blade fell into the patient.The pieces were recovered.This event has been reported to ansm by the customer.It is unknown if there was a back-up device available or if there was a delay.
Event or Problem Description
It was reported that during a hip arthroscopy, pieces of the long incisor elite blade fell into the patient.The pieces were recovered.This event has been reported to ansm by the customer.The procedure was successfully completed with a delay of 5-10 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device was returned with the inner hub stuck in the outer hub, partially withdrawn from the fully seated position.The inner and outer cutting surfaces show wear from use, but there are no fractures.There is biological debris on the returned items.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.Corrected data: h3 (sample returned for analysis).
Event or Problem Description
It was reported that during a hip arthroscopy, pieces of the long incisor elite blade fell into the patient.The pieces were recovered.The procedure was successfully completed with a delay of 5-10 minutes using a smith and nephew back up device.No further complications were reported.

• Brand Name: CURVED LONG INCISOR PLUS ELITE BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18454039
• Report Number: 1219602-2024-00038
• Device Sequence Number: 12548983
• Product Code: HAB
• UDI-Device Identifier: 03596010555915
• UDI-Public: 03596010555915
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72200494
• Device Lot Number: 51062953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 02/29/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/08/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 85 KG